Clinical Trials in China / NCT07139535
Starting soon
Phase 3
A Study of RAY1225 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
NCT07139535 · tracked via the Priya Life Science China tracker
Condition(s) studied
T2DM
Investigational drug(s) / intervention(s)
RAY1225 →placebo
RAY1225: Administered SC
placebo: Administered SC
Study summary
The goal for this study is to evaluate the efficacy and safety of RAY1225 versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.
Eligibility
Inclusion Criteria:
1. Have been diagnosed with type 2 diabetes mellitus (T2DM)
2. Having received only dietary and exercise therapy and never taken any antihyperglycemic medications before screening; OR Having taken no antihyperglycemic medications within the 12 weeks before screening and, prior to that, having received only oral antihyperglycemic drugs in a regimen of no more than two concomitant agents.
3. Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening
4. Be of stable weight (±5%) for at least 12 weeks before screening
Exclusion Criteria:
1. Have type 1 diabetes mellitus
2. Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;
3. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;
4. Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose \<3.0 mmol/L) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;
5. History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;
6. Receipt of blood transfusion within 12 weeks prior to screening, or blood donation/loss ≥400 mL within 12 weeks prior to screening, or blood donation/loss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.);
7. Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.).
Primary outcome measure(s)
- Change From Baseline in Hemoglobin A1c (HbA1c) — Baseline,36 Week
HbA1c is the glycosylated fraction of hemoglobin A.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University People's Hospital | Beijingcun | Hebei |
More Guangdong Raynovent Biotech Co., Ltd trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07139535 on ClinicalTrials.gov ↗ ← All trials in China